Zdrowie i gospodarka · 28/12/2015
Hepatitis C Virus “Lookback” Requirements Based on Review of Historical Testing Records; Technical Amendment
The Food and Drug Administration (FDA) is amending the biologics regulations by removing the Hepatitis C Virus (HCV) "lookback" requirements regarding review of historical testing records. FDA is taking this action because the HCV "lookback" regulations based on review of historical testing records expired on August 24, 2015, due to the sunset provision provided under the regulation.